Z-0199-2018Class II

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage...

Name: Z-0199-2018 DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage...
Creator: DeRoyal Industries Inc
Published: 2017-10-16
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2017-10-16 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray... on 2017-10-16. FDA classified it as Class II and gives the reason as "Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0199-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-16
Posted: 2017-12-06
Terminated: 2020-08-21
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f) Plastic Pack, REF 89-7212.04 g) Plastic Pack, REF 89-7212.05 Product Usage: Custom surgical and procedural kits
Product code: LRO General Surgery Tray
Reason for recall: Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DeRoyal sent an Urgent Recall Notice letter dated October 17, 2017, to the end-user level. The letter identified the affected product, problem and actions to be taken. Consignees were asked to return any product they held in stock to DeRoyal and to complete the Notice of Return Form indicating what they were returning. Credit will be issued. They were asked to complete and return the Notice of Return Form even if they no longer held any affected product. For questions call 865-362-4203.
Quantity in commerce: 5946 units
Distribution: US Nationwide distribution in the states of GA, IN, FL, and PA
Product codes and lots: a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0199-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)